ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of ALKS 37 when administered daily to adults with OIC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• Are at least 18 years of age at time of consent

• Have a body mass index (BMI)of 19 to 35 kg/m2 at screening

• Are receiving prescribed opioid medication for the management of chronic, non-cancer pain

• Meet the criteria of OIC

• Agree to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

• Pregnancy and/or currently breastfeeding

• Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed)

• Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction

• Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction

• Use of naloxone, Subutex or Suboxone, Revia, Vivitrol, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study

• Participation in a clinical trial of a pharmacological agent within 30 days before screening